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1 Clinical Trial Details (PDF Generation Date :- Thu, 28 Mar :01:29 GMT) CTRI Number Last Modified On 28/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/05/ [Registered on: 13/05/2011] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial This study is designed to compare the efficacy, safety and tolerability of two agents (topical Isotretinoin solution 0.1% and topical Adapalene gel 0.1%) in the Treatment of Acne Vulgaris commonly termed as pimples". Comparative Efficacy, Safety and Tolerability of Topical Isotretinoin Solution 0.1% and Topical Adapalene Gel 0.1% in the Treatment of Acne Vulgaris - An open-label, pilot study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) RISOTR Designation Affiliation Protocol Number Details of Principal Investigator Amit Nasa Gorup Leader Phone Fax Designation Affiliation Ranbaxy Laboratories Limited Research and Development, Medical Affairs and Clinical Research 77 B, Sector 18, IFFCO Road, Udyog Vihar Industrial Area amit.nasa@ranbaxy.com Details Contact Person (Scientific Query) Dr Shradhanand Singh Senior Research Scientist Phone Fax Designation Affiliation Ranbaxy Laboratories Limited Research and Development, Medical Affairs and Clinical Research 77 B, Sector 18, IFFCO Road, Udyog Vihar Industrial Area Shradhanand.Singh@ranbaxy.com Details Contact Person (Public Query) Dr Shradhanand Singh Senior Research Scientist Ranbaxy Laboratories Limited Research and Development, Medical Affairs and Clinical Research 77 B, Sector 18, IFFCO Road, Udyog Vihar Industrial Area page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Ranbaxy Laboratories Limited Type of Sponsor NIL List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Ranbaxy Laboratories Limited Research and Development, Medical Affairs and Clinical Research, 77 B, Sector 18, IFFCO Road, Udyog Vihar Industrial Area,, Haryana Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Dr L Aarthi Aarthi Skin Care Clinic Old no. 32, Kummalannan Koil Street, Near Tondiarpet Market, Chennai Chennai TAMIL NADU Dr Mukesh Kumar Jain Dr. Mukesh Jain Clinic 70/70, Madhyam Marg, Mansarovar, Dr Hemanata Kumar Kar Dr Rashid Shaikh Dr RP Singh Dr. R.M.L. Hospital Ethika Clinical Research Center Prakruti Hospital Government Medical College Department of Dermatology, STD & Leprosy, Dr. R.M.L. Hospital New Delhi New Delhi DELHI Ethika Clinical Research Center Prakruti Hospital, 1st Floor, Siddeshwar Arcade, Opp. Manisha Nagar Gate 1, Kalwa Thane West, Mumbai Thane Department of Dermato -Venereo-Leprology Government Medical College Nagpur Nagpur Dr Hirday Gurbaksh JK Skin & Laser Clinic SF-068, 1st Floor, Galleria Complex, DLF-IV, draarthi_derm@hotmail.com drmukesh13@yahoo.co m hkkar_2000@yahoo.co m dr.rashidshaikh@gmail. com rpsingh133@rediffmail. com hriday_gurbaksh@yaho page 2 / 7

3 Details of Ethics Committee Dr Riyaz Aamir Dr Manisha Nijhawan Khobragade Multispeciality Hospital Mahatma Gandhi Medical College and Hospital Khobragade Multispeciality Hospital, Indora Chowk, Kamptee Road, Nagpur Nagpur RIICO Institutional Area, Sitapura, Dr Sanjay Sakarwal Marudhar Hospital A-93-99, Singh Bhoomi Khatipura Dr Dipak Umrigar New Civil Hospital Department of Dermatology, OPD No. 24, First Floor, New Civil Hospital, Majuragate, Surat Surat GUJARAT Dr Puneet Goyal Renova skin care & Laser Clinic Sector-9 Shopping Center, Near Jain Mandir, Madhyam Marg, Mansarovar, Dr Sunil Tolat Skin Clinic Akar Bhavan, Opposite Saraswat Bank, Swargate Pune Pune o.com com m il.com om co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Chennai Ethics committee Ethics committee of Biniwale clinic Human Research Ethics Committee Approved 17/11/2010 Yes Approved 29/01/2011 Yes Approved 22/12/2010 No Institutional Ethics Approved 21/10/2010 No Committee Government Medical College Nagpur Mahatma Gandhi Medical College and Hospital Ethics Committee Approved 06/01/2011 No Meet Ethics Committee Approved 02/11/2010 Yes Midcity Independent Ethics Committee Swasthya Kalyan Ethics committee Approved 03/10/2010 Yes Approved 15/12/2010 Yes Swasthya Kalyan Ethics Approved 13/10/2010 Yes page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee 1 Swasthya Kalyan Ethics Committee 2 Swasthya Kalyan Ethics Committee 3 Status Approved 13/10/2010 Yes Approved 15/12/2010 Yes Date Approved/Obtained 16/12/2010 Health Type Patients Condition Acne Vulgaris Type Details Intervention Isotretinoin solution 0.1% The study involves topical application of Isotretinoin solution 0.1% once daily in the evening or at bedtime after washing the face for 12 weeks. Comparator Agent Adapalene gel 0.1% The study involves topical application of Adapalene gel 0.1% once daily in the evening or at bedtime after washing the face for 12 weeks. Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1.Subjects of either sex aged 12 years and above who have given written informed consent or assent to participate in the study. Additional written informed consent will be taken from parents or LAR as applicable in case assent is taken from subjects aged less than 18 yrs. Note This DCGI approved trial has no upper age limit subjects aged more than or equal to 12 years are inclusive 2. Diagnosis of Facial Acne Vulgaris with a minimum of 15 but not more than 50 facial inflammatory acne lesions papules and or pustules and a minimum of 20 but not more than 100 facial non-inflammatory acne lesions open and or closed comedones 3. Subjects must have a rating of at least grade 2 on Investigators Global Assessment for Acne Vulgaris. However, subjects with nodular acne lesions will not be included. 4. Female subjects of child bearing potential practicing an approved method of contraception and willing to continue its use for the duration of the study and have a negative Serum Pregnancy Test at the time of screening or female subjects of non-child bearing potential. Approved methods of contraception include Hormonal contraception including oral, systemic injectable or Intra-uterine Contraceptive Devices must have been on a stable dose for 6 months prior to study entry, bilateral tubal ligation or tubectomy, non-hormonal IUCD, double barrier or strict abstinence. Non-child bearing potential is defined as premenstrual pre-menarche, postmenopausal absence of menstrual bleeding for 1 page 4 / 7

5 year prior to enrollment,hysterectomy or bilateral oophorectomy Exclusion Criteria Details Exclusion Criteria 1.Subjects with history of hypersensitivity to Isotretinoin, Adapalene or any of the excipients of either of the two formulations or Vitamin A or any other similar drug substances. Excipients of isotretinoin solution are propylene glycol dicaprylate/ dicaprate USNF (Captex 200P), butylated hydroxyanisole USNF, benzoic acid USP Excipients of adapalene gel are carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust ph. 2.Subjects who have been previously diagnosed with an endocrinological disorder likely to cause acne such as genital/adrenal hyperplasia, adrenal tumors or any other hypo androgenetic state. 3.Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, skin cancer, actinic keratosis or psoriasis) which in the opinion of the investigator may affect the action or evaluation of the study medication or place the subject at undue risk. 4.Subjects who are using any of the systemic medications likely to cause or abate acne e.g., oral phenytoin or any other anti-epileptic medication, finasteride, spironolactone, flutamide, testosterone, dietary body-building protein preparations, mega-doses of vitamin D [more than 2000 IU per day], Vitamin A [more than 5000 IU per day] or vitamin B12 [more than 1 mg/day], haloperidol, halogens [e.g., iodide, bromide], lithium or phenobarbital. However, subjects who are using or plan to use multivitamins, iron supplements or folate are acceptable. 5.Subjects having any nodulo-cystic acne lesions. 6.Use of topical corticosteroids or antibiotics or retinoids within the past 2 weeks on the face or systemic corticosteroids or antibiotics within the past 4 weeks or during the study period. However, use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable. 7.Use of facial preparations like abradants, peels, masks, washes, soaps or moisturizers containing glycolic acid, salicylic acid, Alphaor beta-hydroxy acids or other acids, benzoyl peroxide (BPO) or sulfacetamide sodium within the past 2 weeks or during the study period. 8.Subjects who have undergone a facial procedure (e.g., laser peel, microdermabrasion or blue light treatment, etc) within the past 4 weeks or if it is planned to be performed during the conduct of the study. 9.Use of systemic retinoids (e.g., oral isotretinoin) within 6 months prior to subject enrollment or during the study period. 10.Subjects with excessive facial hair that may interfere with study evaluations. 11.Subjects involved in tasks with long exposure to sunlight or use of any known photosensitizing agents like tanning booths, sun lamps, etc during the study period. 12.Subjects with a clinically significant disease(s) or disorder(s) other than facial acne vulgaris that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subjects ability to participate in the study. 13.Subjects with clinically significant abnormal laboratory value page 5 / 7

6 which may affect the participation of the subject in the study. 14.Subjects with evidence of substance abuse as per DSM-IV criteria. 15.Subjects unwilling or unable to comply with the study procedures. 16.Subjects who have participated in another investigational study within the last three months prior to enrollment in this study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Not Applicable Not Applicable Primary Outcome Outcome Timepoints 1. Mean reduction from baseline in acne lesion Week 12 counts (non-inflammatory,inflammatory and total)at week 12 Subjects who achieve clear face (Grade 0 on 2. Proportion of subjects with success defined as IGA scale)before week 12 will be considered as improvement by at least 2 grades in IGA scale treatment success and completor for inclusion in for Acne vulgaris as compared to baseline at the PP analysis week 12 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Mean reduction from baseline in acne lesion counts (non-inflammatory,inflammatory and total)at week 8 Proportion of subjects with success defined as improvement by at least 2 Grades in IGA scale for Acne vulgaris as compared to baseline at week 8 Proportion of subjects with success defined as Grade 0 or 1 on IGA scale for Acne vulgaris at week 8 Subjects with a baseline score of Grade 2 will be considered to have success only if they achieve Grade 0 at week 8. Proportion of subjects with success defined as Grade 0 or 1 on IGA scale for Acne vulgaris at week 12 Subjects with a baseline score of Grade 2 will be considered to have success only if they achieve Grade 0 at week 12. Total Sample Size=120 Sample Size from =120 01/06/2011 No Date Specified Years=1 Months=0 Days=0 Not Applicable Completed Week 8 Week 8 Week 8 Week 12 page 6 / 7

7 Powered by TCPDF ( Publication Details Brief Summary This will be an open-label, randomized, comparative, parallel-group, multicentric, phase II, pilot study of 12 weeks duration. The objective of the study is to compare the efficacy, safety and tolerability of topical Isotretinoin solution 0.1% and topical Adapalene gel 0.1% in the Treatment of Acne Vulgaris. Approximately 120 subjects of either sex aged 12 years and above with a diagnosis of Facial Acne Vulgaris who give written informed consent will be enrolled in the study. Subjects meeting inclusion and exclusion criteria will be randomised to receive one of the two study medications. Study medication should be applied as a thin layer, once daily (in the evening or at bedtime) on the entire face after washing the face with a mild, non-medicated soap and drying the skin. Treatment with study medication will be continued until the subject achieves clear face (Grade 0 on IGA scale) as per discretion of the investigator or up to 12 weeks, whichever is earlier. During the study period, subjects will make a total of 4 visits to the study site: Treatment initiation visit (i.e., Visit 1 on Day -3 to 0), two on therapy visits (i.e., Visit 2 on Day 28 3 and Visit 3 on Day 56 3 ) and an end of study visit (i.e., Visit 4 on Day 84 3). The efficacy will be assessed primarily on the basis of mean reduction from baseline in acne lesion counts (non-inflammatory, inflammatory and total) and proportion of subjects with success defined as improvement by at least 2 Grades in IGA Scale for Acne Vulgaris as compared to baseline, at week 12 (visit 4). However, subjects who achieve clear face (Grade 0 on IGA Scale) before week 12 will be considered as treatment success and completor for inclusion in the PP analysis. The above parameters will also be assessed at week 8 (visit 3) for secondary analysis. In addition, proportion of subjects with success defined as Grade 0 or 1 on IGA Scale for Acne Vulgaris will be assessed at week 8 and 12. Subjects with a baseline score of Grade 2 will be considered to have success only if they achieve Grade 0 at week 8 and 12. Safety will be evaluated by recording Adverse Events (AEs), physical examination, vital signs (body temperature, pulse rate, respiratory rate, sitting blood pressure) and clinical laboratory tests (hematology, biochemistry and urinalysis). AEs will be classified according to their seriousness, severity and relationship to study medication. Any clinically significant change from the baseline in the concurrent medical condition(s), physical examination and/or laboratory data shall also be recorded as an AE. Cutaneous tolerance will be assessed by rating erythema, scaling, dryness and burning/stinging on each visit on a scale of 4 (0=none, 1=mild, 2=moderate, 3=severe). The symptoms of cutaneous tolerance and worsening of IGA score beyond 4 will not be recorded as AEs unless they lead to withdrawal of subject. page 7 / 7